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PSMAfore: A Phase III, Open-label, Multi-Center, Randomized Study Comparing 177Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in the Treatment of Taxane Naïve Men With Progressive Metastatic Castrate Resistant Prostate Cancer

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Trial Profile

PSMAfore: A Phase III, Open-label, Multi-Center, Randomized Study Comparing 177Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in the Treatment of Taxane Naïve Men With Progressive Metastatic Castrate Resistant Prostate Cancer

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Jun 2025

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At a glance

  • Drugs Lutetium (177Lu) vipivotide tetraxetan (Primary) ; Abiraterone; Androgen receptor antagonists; Enzalutamide; Gallium (68Ga) gozetotide
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms PSMAfore
  • Sponsors Novartis; Novartis Pharmaceuticals

Most Recent Events

  • 02 Jun 2025 According to a Novartis Media release, Pluvicto was recently granted US Food and Drug Administration (FDA) approval for earlier use in mCRPC, based on results from PSMAfore.
  • 28 Mar 2025 Results presented in the Novartis Media Release.
  • 04 Jun 2024 Results of exploratory analysis, associations between baseline circulating tumor DNA (ctDNA) and outcomes, presented at the 60th Annual Meeting of the American Society of Clinical Oncology.

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